Adverse Event Terminology

Working Group Chair(s)
Andrea Hanson
Health Products Regulatory Authority (HPRA), Ireland
European Union
Evan Jacobs
Food and Drug Administration (US FDA)
United States of America
Katie Burns (Maintenance Chair)
Therapeutic Goods Administration (TGA)
Australia
Membership
Regulators
Status
Current

The purpose of this working group is to:

  • establish IMDRF adverse event terminology including terms for medical device malfunction, evaluation result/conclusion, patient/user outcome, and part/component of a medical device
  • support the implementation and the use of the terminology through the provision of guidance documents and training materials
  • improve, harmonize and where necessary expand the terminology and systems being used to code information relating to medical device adverse events.

Do you want to find a code? Browse the terms now

Are you looking for guidance on adverse event terminology ? Browse here

Do you wish to submit a request to change the AET Terminology? See this page

Work items

  • Finalisation of the updated Annual Maintenance Standard Operating Procedure (SOP)

  • Review of the N43 Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes and N44 Maintenance of IMDRF AE Terminologies

Participants

Amanda Craig
Therapeutic Goods Administration (TGA)
Katie Burns
Therapeutic Goods Administration (TGA)

Maria Gloria Vicente
Brazilian Health Regulatory Agency (ANVISA)
Stela Candioto Melchior
Brazilian Health Regulatory Agency (ANVISA)

Dale Miranda
Health Canada
Leanne Moore
Health Canada
Richard McAteer
Health Canada

Dr Christena Adel
Egyptian Drug Authority (EDA)
Lamiaa Attia
Egyptian Drug Authority (EDA)
Yomna Hamad
Egyptian Drug Authority (EDA)

Carlos Alejandro Valiente Amaya
National Directorate of Medicines (DNM), El Salvador
Francisco José Alfaro Beltrán
National Directorate of Medicines (DNM), El Salvador

Andrea Hanson
Health Products Regulatory Authority (HPRA), Ireland
Jean-Francois Roche
European Commission
Kathrin Doerr
Federal Institute for Drugs and Medical Devices (BfArM-Germany)

Koko Nakamichi
Pharmaceuticals and Medical Devices Agency (PMDA)
Miho Sato
Pharmaceuticals and Medical Devices Agency (PMDA)
Takumi Fukasawa
Pharmaceuticals and Medical Devices Agency (PMDA)

Safaa Tawahi
Jordan Food And Drug Administration (JFDA)
Tulip Abd Al Jawad
Jordan Food And Drug Administration (JFDA)

Alison Iglesias
National Directorate of Health Surveillance (DINAVISA)
Carolina Montiel
National Directorate of Health Surveillance (DINAVISA)
Chang Cho
National Directorate of Health Surveillance (DINAVISA)

Ali Alhawas
Saudi Food and Drug Authority (SFDA)
Azzam Alothman
Saudi Food and Drug Authority (SFDA)

Lailing Liew
Health Sciences Authority (HSA)

Hyung-Beom Kim
Ministry of Food and Drug Safety (MFDS)
Hyunjin Kim
Ministry of Food and Drug Safety (MFDS)
Jiyeong Im
Ministry of Food and Drug Safety (MFDS)
Rosa Da-yeong Ryoo (Ms)
Ministry of Food and Drug Safety (MFDS)

Cyrill Reber
Swissmedic
Eva Brombacher
Swissmedic
Sandra Tanner
Swissmedic

Sarah El Amin
Ministry of Health, Labour and Welfare (MHLW)
Sarah Vaughan
Medicines and Healthcare products Regulatory Agency (MHRA)

Deepa Peck
Food and Drug Administration (US FDA)
Evan Jacobs
Food and Drug Administration (US FDA)

Anita Sands
World Health Organization (WHO)
Leticia Josefina Megias Lastra
World Health Organization (WHO)